Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2459
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Hypaque Sodium (Injection, Solution)
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Intravenous Dosage: Adults: A dose of 30 mL to 60 mL produces excellent shadows in the majority of adults subjected to partial dehydration and effective purgation. In persons of slight build, 20 mL produces adequate shadows. For best results and minimal reactions, the total 30 mL to 60 mL should be injected in one to three minutes and compression may be used. A small intravenous test dose may be administered as a possible aid in determining sensitivity to the medium. Children: The suggested dosage for children up to 12 years old is presented in the table below. Children older than 12 years may be given an adult dose.<br/>Preliminary Preparation of Patient: Although clear shadows are often seen in patients who have had no preliminary preparation for urography, the largest percentage of satisfactory films is obtained in patients who abstain from fluids for 12 to 15 hours before the intravenous injection so that partial dehydration results. Unless contraindicated, a laxative may be taken at bedtime to eliminate gas from the intestine.<br/>Roentgenographic Technique: A preliminary scout film may be obtained before the intravenous injection. Excellent shadows can often be obtained immediately after administration of the radiopaque medium (within a five-minute period). If preliminary preparation has been carried out, the urinary organs are usually best visualized on films exposed 5, 10, or 15 minutes after intravenous injection. If a film of the bladder is required, it is generally taken 25 or 35 minutes after injection. In patients with impaired renal function, the best shadows may not be obtainable until later (30 minutes or more) because of delayed excretion, and additional film may have to be exposed. Most urologists and roentgenologists believe that compression immediately above the symphysis (obtained by application of a small hollow rubber ball about the size of a grapefruit or by the rolled bed sheet technique) assures adequate filling of the pelves and ureters, and hence is of great value. Although compression undoubtedly improves the urogram, it also seems to increase the possibility of pyelorenal backflow or reflux by raising the pressure within the urinary tract.
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HYPAQUE meglumine, brand of diatrizoate meglumine, is a water-soluble, radiopaque diagnostic medium. It is a triiodinated benzoic acid derivative containing 47.06 percent organically bound iodine. It is constituted as an iodinated anion (diatrizoate) and a radiolucent cation (meglumine). HYPAQUE meglumine 60 percent (w/v) is a sterile aqueous solution containing 60 g of the meglumine salt of diatrizoic acid per 100 mL of solution. The solution is a clear-colorless to pale yellow liquid, and the pH is adjusted between 6.5 and 7.7 with diatrizoic acid or meglumine solution. It is a relatively thermostable solution and may be autoclaved without harmful effects, although it should be protected from strong light. The 60 percent solution contains edetate calcium disodium 1:10,000 as a sequestering stabilizing agent. Each 1 mL contains approximately 282 mg of organically bound iodine. The viscosity of the solution is 6.17 cp at 25��C and 4.12 cp at 37��C. It is hypertonic to blood with an osmolality of 1415 mosm/kg (determined by VPO). A 13 percent solution (w/v) is isotonic. It is a colorless, microcrystalline solid which is readily soluble in water. It is meglumine 3,5-diacetamido-2,4,6-triiodobenzoate (CHINO���CHNO) with a molecular weight of 809.13, and has the following structural formula:
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Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs. At physiologic pH, the water soluble contrast media are completely dissociated into a radiopaque anion and a solubilizing cation. While circulating in tissue fluids, the compound remains ionized. However, it is not metabolized but excreted unchanged in the urine, each diatrizoate molecule remaining "obligated" to its meglumine moiety. Following intravenous injection, the radiopaque diagnostic agents are immediately diluted in the circulating plasma. Equilibrium is reached with the extracellular compartment at about 10 minutes. Hence, the plasma concentration at 10 minutes is closely related to the dose corrected to body size. The pharmacokinetics of the intravenously administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slow beta phase for drug elimination. In patients with normal renal function, the alpha and beta half-lives were respectively 30 minutes and 120 minutes for diatrizoate. But in patients with renal functional impairment, the elimination half-life for the beta phase can be prolonged up to several days. Injectable radiopaque diagnostic agents are excreted either through the liver or through the kidneys. The two excretory pathways are not mutually exclusive, but the main route of excretion seems to be governed by the affinity of the contrast medium for serum albumin. From 0% to 10% of diatrizoate sodium is bound to serum protein. Diatrizoate salts are excreted unchanged predominantly through the kidneys by glomerular filtration. The amount excreted by the kidney during any period of time is determined by the filtered load; ie, the product of plasma contrast media concentration and glomerular filtration rate. The plasma concentration is dependent upon the dose administered and the body size. The glomerular filtration rate varies with the body size, sex, age, circulatory dynamics, diuretic effect of the drug, and renal function. In patients with normal renal function the maximum urinary concentration of diatrizoate meglumine occurs within 10 minutes with 12 percent of the administered dose being excreted. The mean values of cumulative urinary excretion for diatrizoate meglumine expressed as percentage of administered dose are 38 percent at 60 minutes, 45 percent at 3 hours, and 94 to 100 percent at 24 hours. Urinary excretion of contrast media is delayed in infants younger than 1 month and in patients with urinary tract obstruction. The urinary iodine concentration is higher with the sodium salt of diatrizoic acid than with the meglumine salt. The liver and small intestine provide the major alternate route of excretion for diatrizoate. In patients free of severe renal disease, the fecal recovery is less than 2 percent of the administered dose. In patients with severe renal impairment the excretion of these contrast media through the gallbladder and into the small intestine sharply increases; up to 20 percent of the administered dose has been recovered in the feces in 48 hours. Saliva is a minor secretory pathway for injectable radiopaque diagnostic agents. In patients with normal renal function, minimal amounts of contrast media are secreted unchanged. However, in uremic patients small amounts of free iodides resulting from deiodination prior to administration or in vivo, have been detected in the saliva. Diatrizoate salts cross the placental barrier in humans by simple diffusion and appear to enter fetal tissue passively. No apparent harm to the fetus was observed when diatrizoate sodium and diatrizoate meglumine were injected intravenously 24 hours prior to delivery. However, abnormal neonatal opacification of the small intestine and colon were detected 4 to 6 days after delivery. Procedures including radiation involve a certain risk related to the exposure of the fetus. Injectable radiopaque diagnostic agents are excreted unchanged in human milk.<br/>Computerized Tomography: HYPAQUE meglumine 60 percent can be administered as an intravenous bolus for brain tissue enhancement using computerized tomography. Increased tissue contrast differential for the scan is achieved either because of increased vascular (arterial, venous, or capillary bed) contrast or by blood brain barrier penetration of the medium (or its absence) in certain localized areas of disrupted vascular permeability. The degree of tissue enhancement caused by increased blood contrast is directly related to blood iodine content. However, the degree of enhancement due to extravascular accumulation of iodine resulting from blood brain barrier disruption will depend on the extent of disruption, the blood level of iodine, and the time delay prior to scanning. The nature of the pathology will determine whether an immediate or delayed scan isoptimal.<br/>Effects of Steroid Therapy: The anti-inflammatory and antiedema effects in patients receiving steroid therapy have interfered with the expected distribution of CT tissue enhancement on the scan in certain diseases.
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Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0746-04). Vials of 100 mL, rubber stoppered, box of 10 (NDC 0407-0747-02). Box of 10 calibrated 200 mL dilution bottles with hangers containing 150 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0749-20). Box of 10 calibrated 200 mL dilution bottles with hangers containing 200 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0750-10). Protect from light. Store at 15��C to 30��C (59��F to 86��F).
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At dosage levels of 1 mL/lb, the incidence of unpleasant side effects increases. At total dosage of 2 mL/lb, administered over a short period of time (eg, 30 minutes), clinical signs of systemic intolerance appear (mostly related to hyperosmolar effects) and are manifest as tremors, irritability, and tachycardia. Above these maximal tolerated dosage levels in otherwise healthy adults, an increasing incidence and severity of dyspnea and pulmonary edema should be expected. Four cases of overdosage in infants, during urography, are reported. Three of the infants died within 19 hours of the injection. The overdose ranged from slightly above the recommended pediatric dosage to a dose exceeding 19 g/kg. The symptoms of overdosage appeared between 10 minutes to several hours after injection of the contrast medium. Adverse effects were life-threatening, affecting mainly the pulmonary and cardiovascular systems. The symptoms included: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. All infants showed a poor visualization of the kidneys and a diffuse opacification of all the tissues and vasculature. Autopsy findings showed acute pulmonary damage and/or edema of subcutaneous tissues. Treatment of an overdose of injectable radiopaque contrast media is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. The acute intravenous LDof diatrizoate meglumine in mice is equivalent in iodine content of 5.3 gI/kg to 8.0 gI/kg and seem to be directly proportional to the rate of injection. Diatrizoate meglumine is dialyzable.
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Diatrizoate Meglumine
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Hypaque Sodium (Injection, Solution)
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See ADVERSE REACTIONS���General.
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HYPAQUE meglumine 60 percent is indicated for excretory urography; cerebral angiography; peripheral arteriography; venography; operative, T-tube, or percutaneous transhepatic cholangiography; splenoportography; arthrography; discography; and contrast enhancement of computed tomographic head imaging.<br/>Urography: Diatrizoate salts are used in small, medium, and large dose urography . Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures. Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction .<br/>Contrast Enhancement of Computed Tomographic Head Imaging: Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.<br/>Tumors: Radiopaque diagnostic agents may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of normal studies.<br/>Nonneoplastic Conditions: The use of injectable radiopaque diagnostic agents may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60 percent of cerebral infarctions studied from one to four weeks from the onset of symptoms. Sites of active infection may also be enhanced following contrast media administration. Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.<br/>Angiography: Diatrizoate salts are used for radiographic studies throughout the cardiovascular system. Intravascular radiopaque diagnostic agents of high concentration are not recommended for cerebral or spinal angiography , and contrast agents with the lowest compatible viscosity and higher concentration of iodine (310 mg/mL to 480 mg/mL of bound iodine) must be used for angiocardiography. Contrast media approaching serum ionic content and osmolality have less potential for deleterious effects on the myocardium . Addition of chelating agents may contribute to toxicity in coronary angiography, and the sodium content of angiographic agents used in coronary arteriography is of crucial importance. In addition to the following general CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures.
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Hypaque Sodium
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